Draegar Medical Systems: Infinity Dual Hemo MCable Pod Recall - Liquid Ingress Risk
Draegar Medical Systems recalls Infinity Dual Hemo MCable Pods with Revision Indexes 15 or 16 due to potential liquid ingress causing inaccurate blood pressure readings. Affected units may be sold in medical settings.
Lower-risk recall
Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Dr¿ger Infinity Acute Care System, may permit liquid ingress inconsistent with their IPX4 rating, which could potentially result in an incorrect measured value of invasive blood pressure.
Contact the company
What happened, in plain English
Draegar Medical Systems is recalling Infinity Dual Hemo MCable Pods with Revision Indexes 15 or 16. These pods may allow liquid to enter, leading to incorrect blood pressure measurements in medical devices. Read more at govinfonow.com/recall/72912-draegar-medical-systems-infinity-dual-hemo-mcable-pod-recall-liquid.
Source Summary by GovInfoNow · govinfonow.com/recall/72912-draegar-medical-systems-infinity-dual-hemo-mcable-pod-recall-liquid · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0942-2018
Cite this page
“Draegar Medical Systems: Infinity Dual Hemo MCable Pod Recall - Liquid Ingress Risk.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72912-draegar-medical-systems-infinity-dual-hemo-mcable-pod-recall-liquid. Based on FDA recall #Z-0942-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0942-2018%22&limit=1).
Why it’s dangerous
The pods may let liquid enter despite their IPX4 rating, which is designed to prevent water ingress. This could cause inaccurate blood pressure readings, potentially leading to incorrect medical decisions.
Who’s affected
Medical professionals using the Infinity Acute Care System with the affected revision indexes are most at risk. Patients receiving blood pressure monitoring via this device could be impacted.
How to tell if you have this one
Check the product label for Revision Indexes 15 or 16. The affected pods are used with the Dr¿ger Infinity Acute Care System.
- Brand
Draeg: Medical Systems- Category
Medical device
What to do — step by step
Check Product Label
Look for Revision Indexes 15 or 16 on the product label to identify affected units.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationally” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0942-2018 (October 4, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0942-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.